AmCham Position Paper on the Pre-Consultation for the Amendment of the Reimbursement Act

The Ministry of Health has completed the pre-consultation phase regarding amendments to the Reimbursement Act, aimed at clarifying the regulations. AmCham has identified six areas requiring urgent changes due to several potentially negative consequences associated with the implementation of the new regulations.

The six areas identified by AmCham for urgent amendments are as follows:

1. Abandonment of the new rules for calculating minimum supply quantities specified in Article 25, point 4 of the Reimbursement Act, and reverting this provision to the wording that was in effect before November 1, 2023. This means returning to the practice where applicants declare supply quantities according to the actual demand of patients for a given drug and their logistical-production capabilities.
2. Revocation of provisions requiring the Ministry of Health to dismiss reimbursement proceedings if the applicant fails to supplement, within the deadline, analyses submitted with the application that, in the opinion of the President of AOTMiT, do not meet the requirements specified in the executive regulations, and documentation confirming the fulfillment of additional conditions recommended by the President of AOTMiT. These regulations could lead to premature dismissal of reimbursement proceedings, potentially delaying access to modern therapies.
3. Restoration of the previous wording of regulations governing the creation of limit groups and removal of provisions allowing changes to reimbursement decisions during their term based on discretionary criteria. This introduces unpredictability and undermines the principle of administrative decision stability, causing applicants to worry about the conditions of reimbursement during the decision period agreed upon during negotiations. This could destabilize the reimbursement system, affecting both applicants and patients, as the structure of the limit group determines the co-payment amount for reimbursed drugs in pharmacies.
4. Ensuring legal certainty for applicants by introducing a procedure to inform applicants of planned changes, combined with allowing them to apply for amendments to the risk-sharing instrument based on appropriate regulations. The right granted to the Ministry of Health by DNUR to unilaterally change the descriptions of drug programs continues to raise concerns among applicants about potential discrepancies between such changed descriptions and the agreements reflected in the risk-sharing instrument.
5. Revocation of the provision allowing agreements with any countries under which Poland would share sensitive information about effective prices or other details of risk-sharing instruments. Establishing new platforms for exchanging confidential information regarding the reimbursement conditions of specific products in Poland could pose a significant threat to the stability of operations conducted by pharmaceutical companies with an international or global reach.
6. Removal of the provision imposing criminal liability on individuals signing reimbursement applications for the accuracy of the data and information contained therein, as this liability is disproportionately severe compared to the actual ability of these individuals to verify the data. Each reimbursement application compiles data and information from various individuals often located in different countries, and those signing in Poland lack the ability to verify all the data.

One of the potential consequences of retaining the current regulations could be the reduced availability of modern therapies for patients due to the uncertainty surrounding the practical application of these regulations. This could reverse the recent trend in Poland of a dynamic increase in the number of reimbursed new therapies, sometimes making Poland one of the first countries in the European Union to do so.

AmCham’s position paper submitted in the pre-consultations is available here.